MAUDE Adverse Event Report: EBI, LLC. SFLX 5 COIL; BHS NON-INVASIVE STIMULATOR (COIL)

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

Zimvie complaint (b)(4).Date of event: the event occurred sometime in (b)(6) 2022.Medical product: unknown.Therapy date: unknown.Customer has indicated that the product is in process of being returned to zimvie for investigation.Once the investigation is complete, a supplemental medwatch 3500a will be submitted.

Event Description

Unit gets very hot and is uncomfortable to use as per cs rep ana maria lepiana, it was reported by the sales rep that the patient finds the bhs unit uncomfortable and the unit gets very hot.Sales rep requested to switch to an opak, he was advised to forward a new rx and dr not explaining why there should be a switch.(b)(6) received the signed and dated rx and note from the doctor., sales rep was advised he can apply the opak from his trunk stock and to pick up the complete bhs unit including the coils from the patient.A return label was sent to the sales rep.

• Brand Name: SFLX 5 COIL
• Type of Device: BHS NON-INVASIVE STIMULATOR (COIL)
• Manufacturer (Section D): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer (Section G): EBI, LLC.; 1 gatehall dr; parsippany NJ 07054
• Manufacturer Contact: stephanie smith ; 1 gatehall dr; parsippany, NJ 07054 ; 9732999300
• MDR Report Key: 15991872
• MDR Text Key: 305583624
• Report Number: 0002242816-2022-00159
• Device Sequence Number: 1
• Product Code: LOF
• UDI-Device Identifier: 00812301020492
• UDI-Public: 00812301020492
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P790002/S026
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 1068224
• Device Lot Number: N/A
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Sex: Female